Clinical trials and research - Ethics committees
- Introduction
- Types of research
- How research addresses what we don't know
- What are clinical trials?
- Different stages of trials
- About fair tests
- Getting involved in health research
- Joining a clinical trial
- Finding out about the results
- Why all research should be registered
- Systematic reviews and meta-analyses
- How trials are regulated
- Ethics committees
- Data monitoring committees
- When things go wrong
- Sheilas-story
- 'The nurse made sure I understood the risks'
- 'I'm here because of women who took part in research'
- 'I thought it might help me or someone else'
- 'I want people to find better medicines'
- 'I can control my Parkinson's thanks to animal research'
- 'I'm lucky I found a trial that was so right for me'
Every clinical trial is covered by regulations that protect the health, safety and dignity of the people taking part.
Research ethics committees
All medical research involving people in the UK, whether in the NHS or the private sector, has to be approved by an independent research ethics committee. The committee protects the rights and interests of the people who will be in the trial.
The committees are often based at local hospitals and are formed of local people, such as healthcare professionals, patients, lawyers and members of the public. They have to include members who aren't healthcare professionals.
Submitting a protocol
Before they start a trial, researchers have to submit a detailed plan of their proposed research (protocol) to a recognised research ethics committee. They may also need approval from other regulators.
All clinical trials of medicines need to be authorised by the Medicines and Healthcare Products Regulatory Agency (MHRA), as do studies on medical devices.
An online system called the Integrated Research Application System (IRAS) allows researchers to use a single set of information to apply to the research ethics committee and other regulators.
Patient information
Researchers have to prepare an information leaflet about their trials for patients. The research ethics committee checks this is clear and accurate.
All those who take part in the trial are given the leaflet, with an opportunity to take it away and discuss it with friends and relatives.
The leaflet has to be in plain language, avoiding technical medical words. It has to make clear:
- the research questions the trial is trying to answer
- who can and can't take part in the trial
- how those taking part in the trial will be treated and what they'll need to do
- what treatment or other intervention is being used
- what type of research it is
- what the possible risks are to participants
- what the possible benefits are to participants
- who is carrying out the trial and who is funding it
- who participants should talk to if they have further questions
Until a research ethics committee approves a clinical trial, researchers can't ask any participants to join it.
The committees are independent both of the researchers whose work they are reviewing and those who pay for the research.
The ethics committees that review clinical trials in the NHS are part of the Health Research Authority's National Research Ethics Service (NRES). NRES publishes plain-language summaries of clinical trials that can be understood by anyone.
Regulating animal research
There are extensive regulations to ensure the welfare of animals in research.
These include regular inspections from government officials, and a requirement for researchers to explain their research ideas and pass an approval process before they start.
The GOV.UK website has more information about research and testing using animals.
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